A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

NCT ID: NCT02962440

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-01-31

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Somapacitan

Group Type: EXPERIMENTAL

somapacitan

Intervention Type: DRUG

All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing \[3H\]-somapacitan

Interventions

somapacitan

All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing \[3H\]-somapacitan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male, aged 45-64 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) 20.0-29.9 kg/m^2 (both inclusive)
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria

• Male of reproductive age who or whose partner(s) is not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) for at least 4 months after dosing or male who is not willing to refrain from donating semen for at least 4 months after dosing. Acceptable forms of prevention include complete sexual abstinence, surgically sterilisation, that the subject uses a condom during intercourse or that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
• Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Occasional use of paracetamol is permitted.
• Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Groningen, , Netherlands

Countries

Netherlands

References

Helleberg H, Bjelke M, Damholt BB, Pedersen PJ, Rasmussen MH. Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects. Eur J Pharm Sci. 2021 Dec 1;167:106030. doi: 10.1016/j.ejps.2021.106030. Epub 2021 Oct 1.

Reference Type: DERIVED

PMID: 34601071 (View on PubMed)

Other Identifiers

2016-000096-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1178-1251

Identifier Type: OTHER

Identifier Source: secondary_id

NN8640-4237

Identifier Type: -

Identifier Source: org_study_id